Small Airways Disease Functional Assessment in Idiopathic Pulmonary Fibrosis (SWIFT-IPF)

NCT07312305 | Recruiting

• 1 other identifier: SWIFT-IPF
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Idiopathic Pulmonary Fibrosis (IPF) is a chronic, fibrosing, and progressive lung disease of unknown cause, whose incidence increases proportionally from the age of 60. It is characterized by a poor prognosis. Antifibrotic therapy can slow the progression of the disease and reduce mortality, but the life expectancy is less than 7-10 years in the vast majority of patients with IPF. There are no studies in the literature that have evaluated the presence of small airway disease in patients with IPF prior to the initiation of pharmacological therapy, using the nitrogen washout test. This test is currently considered the only non-invasive method capable of detecting ventilation inhomogeneity and closing volume, which are indicators of small airway dysfunction. The investigators carried out an Italian prospective, observational, multicenter study with the primary aim to assess the prevalence of small airway disease measured by the nitrogen washout test (evaluating the following functional parameters: phase 3 slope, closing volume, closing capacity, closing volume/vital capacity, closing capacity/total lung capacity, and phase 4 slope) in a group of patients with IPF at the time of diagnosis, before the initiation of antifibrotic therapy. During outpatients visits clinical, functional and radiological data will be collected. Results will be compared to an healthy control group matched with IPF population. Variations in small airways disease parameters will be assessed after one year of antifibrotic treatment.

Conditions

Idiopathic Pulmonary Fibrosis; Small Airways Disease

Keywords

IPF; SAD; SBW-N₂

Outcome Measures

Primary Outcomes (1)

• Prevalence of small airway disease in a group of patients with IPF at the time of diagnosis, before the initiation of antifibrotic therapy.

  To evaluate the percentage of patients with IPF at the time of diagnosis, before the initiation of antifibrotic therapy, with small airway disease measured by the nitrogen washout test (assessing the following functional parameters: phase 3 slope, closing volume, closing capacity, closing volume/vital capacity, closing capacity/total lung capacity, and phase 4 slope).

  1 year

Secondary Outcomes (11)

• Relationship between computed tomography (CT) features and functional parameters indicative of small airway disease.

  1 year

• To compare the indices of small airway dysfunction and the prevalence of small airway disease in patients with IPF and age-matched healthy subjects

  1 year

• Relationship between clinical and epidemiological characteristics of the cohort and the presence and severity of small airway disease

  1 year

• Prevalence of small airway disease in patients with IPF and concomitant emphysema with patients with IPF alone

  1 year

• Correlation between functional characteristics, parameters of small airway dysfunction and fibrosis extent indices on chest CT-scan

  1 year

Study Arms (1)

IPF

IPF of any severity degree, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with IPF of any severity diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines, attending the specialist outpatient clinics of the Pulmonology Units of ASST Santi Paolo e Carlo and ASST Fatebenefratelli-Sacco (Milan, Italy).

You may qualify if:

• Age over 18 years
• IPF of any degree of severity, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines

You may not qualify if:

• Refusal to participate in the study
• Patients unable to provide informed consent for participation in the study
• IPF exacerbation in the 6 months prior to enrollment
• Previous diagnosis of chronic airway disease (e.g., bronchial asthma, chronic obstructive bronchitis, bronchiectasis with a cause other than IPF)
• Presence of bronchial obstruction defined by an FEV1/FVC (or FEV1/VC) ratio below the lower limit of normal
• Chronic therapy with long-acting bronchodilators or combinations of bronchodilators and inhaled corticosteroids
• Inability of the patient to perform reproducible pulmonary function tests
• Chronic treatment with systemic corticosteroids or immunosuppressants
• Concomitant lung or pleural cancer
• Pregnancy or breastfeeding women

Sponsors & Collaborators

• University of Milan: lead

Study Sites (2)

Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)

Milan, Lombardy, 20142, Italy

RECRUITING

Division of Respiratory Diseases, L. Sacco University Hospital, ASST Fatebenefratelli-Sacco, Milan, Italy. Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, Milano, Italy

Milan, Lombardy, Italy

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associated Professor of Respiratory Medicine

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 31, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2027
• Last Updated: January 28, 2026

Record last verified: 2025-10

Locations

IT (2)